https://doi.org/10.4081/monaldi.2023.2793
Unveiling vaccine safety: a narrative review of pharmacovigilance in India's COVID-19 vaccination
Submitted: September 26, 2023
Accepted: November 29, 2023
Published: December 1, 2023
Accepted: November 29, 2023
Abstract Views: 672
PDF_EARLY VIEW: 296
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All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.
Authors
In India, a robust vaccine pharmacovigilance system is essential to the effective implementation of COVID-19 immunization programs, ensuring the safety and efficacy of the administered vaccines. The National Expert Group on Vaccine Administration for COVID-19 and the Pharmacovigilance Programme of India have played vital roles in monitoring and analyzing adverse events following immunization (AEFI). These tools have made it easier to gather, assess, and report information about different adverse drug reactions connected to COVID-19 vaccines. However, there are several issues with India's vaccination pharmacovigilance, including underreporting and sluggish data gathering. To improve the efficiency of the pharmacovigilance system, it is crucial to address these issues and encourage active reporting by healthcare professionals and the general public. This insightful review article serves as a critical resource for shedding light on India's vaccine pharmacovigilance efforts throughout the COVID-19 vaccination drive. It also elucidates how these efforts are pivotal in bolstering public confidence in vaccines. The comprehensive coverage of reported AEFI not only showcases the commitment to vaccine safety but also helps healthcare professionals and policymakers make informed decisions to enhance the overall vaccination program.
World Health Organization. India: WHO Coronavirus disease (COVID-19) dashboard with vaccination data. Available from: https://covid19.who.int/region/searo/country/in.
Rodrigues CMC, Plotkin SA. Impact of vaccines; health, economic and social perspectives. Front Microbiol 2020;11:1526.
DOI: https://doi.org/10.3389/fmicb.2020.01526
Agrawal G, Hermann R, Møller M, et al. Fast-forward: will the speed of COVID-19 vaccine development reset industry norms? Available from: https://www.mckinsey.com/industries/life-sciences/our-insights/fast-forward-will-the-speed-of-covid-19-vaccine-development-reset-industry-norms.
Kumar VM, Pandi-Perumal SR, Trakht I, Thyagarajan SP. Strategy for COVID-19 vaccination in India: the country with the second highest population and number of cases. NPJ Vaccines 2021;6:60.
DOI: https://doi.org/10.1038/s41541-021-00327-2
Geographic Insights. India COVID-19 vaccine tracker. 2021. Available from: https://geographicinsights.iq.harvard.edu/IndiaVaccine.
Larson H, de Figueiredo A, Karafillakis E, Rawal M. State of vaccine confidence in the EU 2018. A report for the European Commission. 2018. Available from: https://health.ec.europa.eu/system/files/2018-11/2018_vaccine_confidence_en_0.pdf.
Chandler RE. Optimizing safety surveillance for COVID-19 vaccines. Nat Rev Immunol 2020;20:451-2.
DOI: https://doi.org/10.1038/s41577-020-0372-8
Sallam M. COVID-19 Vaccine hesitancy worldwide: a concise systematic review of vaccine acceptance rates. Vaccines (Basel) 2021;9:160.
DOI: https://doi.org/10.3390/vaccines9020160
Solís Arce JS, Warren SS, Meriggi NF, et al. COVID-19 vaccine acceptance and hesitancy in low- and middle-income countries. Nat Med 2021;27:1385-94.
DOI: https://doi.org/10.1101/2021.03.11.21253419
Dhalaria P, Arora H, Singh AK, Mathur M, Ajai KS. COVID-19 vaccine hesitancy and vaccination coverage in India: an exploratory analysis. Vaccines (Basel) 2022;10:739.
DOI: https://doi.org/10.3390/vaccines10050739
Local Circles. Local Circles 11.5 crore Indian adults are still hesitant to take COVID vaccine. 2021. Available from: https://www.localcircles.com/a/press/page/localcircles-vaccine-hesitancy-survey.
Chandani S, Jani D, Sahu PK, et al. COVID-19 vaccination hesitancy in India: state of the nation and priorities for research. Brain Behav Immun Health 2021;18:100375.
DOI: https://doi.org/10.1016/j.bbih.2021.100375
CIOMS/WHO Working Group on Vaccine Pharmacovigilance. Definition and application of terms for vaccine pharmacovigilance. 2012. Available from: https://cioms.ch/wp-content/uploads/2017/01/report_working_group_on_vaccine_LR.pdf.
The New Indian Express. India gets fifth Covid vaccine as Johnson & Johnson’s single-shot vaccine gets nod. 2021. Available from: https://www.newindianexpress.com/nation/2021/aug/07/india-gets-fifth-covid-vaccine-as-johnson--johnsons-single-shot-vaccine-gets-nod-2341527.html.
The Financial Express. Covid-19: Zydus Cadila’s ZyCov-D vaccine gets nod for emergency use in India — here’s everything you must know about country’s sixth vaccine. 2021. Available from: https://www.financialexpress.com/lifestyle/health/covid-19-zydus-cadilas-zycov-d-vaccine-gets-nod-for-emergency-use-in-india-heres-everything-you-must-know-about-countrys-sixth-vaccine/2314938/.
Mohandas S, Yadav PD, Shete-Aich A, et al. Immunogenicity and protective efficacy of BBV152, whole virion inactivated SARS- CoV-2 vaccine candidates in the Syrian hamster model. iScience 2021;24:102054.
DOI: https://doi.org/10.1016/j.isci.2021.102054
Serum Institue of India. fact sheet for vaccine recipient approved for restricted use in emergency situation of Chadox1 Ncov-19 Corona Virus vaccine (recombinant) Covishieldtm in prevention of Covid-19 disease in individuals 18 years of age and older. 2021. Available from: https://www.seruminstitute.com/pdf/covishield_fact_sheet.pdf.
DOI: https://doi.org/10.1016/j.nerep.2021.100006
World Health Organization. Main operational lessons learnt from the WHO Pandemic Influenza A(H1N1) Vaccine Deployment Initiative. (2012). Main operational lessons learnt from the WHO pandemic influenza A(H1N1) vaccine deployment initiative. 2011. Available from: https://apps.who.int/iris/handle/10665/44711.
Mokdad AH, Hotez PJ, Orenstein WA. We have to get it right: ensuring success. EClinicalMedicine 2021;31:100690.
DOI: https://doi.org/10.1016/j.eclinm.2020.100690
Naniche D, Hotez P, Bottazzi ME, et al. Beyond the jab: a need for global coordination of pharmacovigilance for COVID-19 vaccine deployment. EClinicalMedicine 2021;36:100925.
DOI: https://doi.org/10.1016/j.eclinm.2021.100925
Sultana J, Mazzaglia G, Luxi N, et al. Potential effects of vaccinations on the prevention of COVID-19: rationale, clinical evidence, risks, and public health considerations. Expert Rev Vaccines 2020;19:919-36.
DOI: https://doi.org/10.1080/14760584.2020.1825951
Kalaiselvan V, Thota P, Singh GN. Pharmacovigilance programme of India: recent developments and future perspectives. Indian J Pharmacol 2016;48:624-8.
DOI: https://doi.org/10.4103/0253-7613.194855
Kalaiselvan V, Prasad T, Bisht A, et al. Adverse drug reactions reporting culture in pharmacovigilance programme of India. Indian J Med Res 2014;140:563-4.
Olsson S. The role of the WHO programme on International Drug Monitoring in Coordinating Worldwide Drug Safety Efforts. Drug Saf 1998;19:1-10.
DOI: https://doi.org/10.2165/00002018-199819010-00001
Kumar Mall S, Dipa P, Goswami S, et al. Pharmacovigilance programme in India (PvPI): history, current scenario, future aspects and role in COVID-19. Asian J Res Pharm Sci 2022;205-9.
DOI: https://doi.org/10.52711/2231-5659.2022.00036
Immunization Focus World Health Organization Regional Office For The Western Pacific Manila. Immunization safety surveillance: guidelines for managers of immunization programmes on reporting and investigating adverse events following immunization. 1999. Available from: https://apps.who.int/iris/bitstream/handle/10665/208312/9290611820_eng.pdf?sequence=1&isAllowed=y.
Ministry of Health and Family Welfare. Revised AEFI guidelines: executive summary. Available from: https://main.mohfw.gov.in/sites/default/files/Revised%20AEFI%20Guidelines%20Execute%20Summary.pdf.
Ministry of Health and Family Welfare, Government of India. Guidelines for integration of Co-WIN with third-party applications developed by ecosystem partners. 2021. Available from: https://www.mohfw.gov.in/pdf/CoWINAPIGuidelinesFinal240521.pdf.
Singh K, Verma A, Lakshminarayan M. India’s efforts to achieve 1.5 billion COVID-19 vaccinations: a narrative review. Osong Public Health Res Perspect 13;316-27.
DOI: https://doi.org/10.24171/j.phrp.2022.0104
Government of India, Ministry of Health & Family Welfare, Immunization Division. Causality assessment results of 88 reported serious adverse events following immunization (AEFI) cases following COVID-19 vaccination approved by national AEFI committee on 28th June 2021. 2021. Available from: https://main.mohfw.gov.in/sites/default/files/Englishnote.pdf.
Gandhi AP, Venkatesh U, Murali N. Serious adverse event following immunization and thromboembolic events associated with COVID19 vaccination: an analysis of nationwide causality assessment from India. Indian Heart J 2023;75:139-44.
DOI: https://doi.org/10.1016/j.ihj.2023.02.004
Basavaraja CK, Sebastian J, Ravi MD, John SB. Adverse events following COVID-19 vaccination: first 90 days of experience from a tertiary care teaching hospital in South India. Ther Adv Vaccines Immunother 202;9:25151355211055833.
DOI: https://doi.org/10.1177/25151355211055833
Sathyapalan DT, Moni M, Prasanna P, et al. Adverse events associated with Covishield vaccination among healthcare workers in a tertiary hospital in South India. Vaccine X 2022;12:100210.
DOI: https://doi.org/10.1016/j.jvacx.2022.100210
Deb T, Beniwal A, Kamra N, Kaur M. ADR Profile of Covishield and Covaxin among young adults (18-45 year) in a district in northern India: a comparative study. Int J Toxicol Pharmacol Res 2022;12:187-94.
Jhaj R, Chaudhary D, Shukla AK, Yadav J. Stimulated reporting of adverse events following immunization with COVID-19 vaccines. Vaccines (Basel) 2022;10:2133.
DOI: https://doi.org/10.3390/vaccines10122133
Beatty AL, Peyser ND, Butcher XE, et al. Analysis of COVID-19 vaccine type and adverse effects following vaccination. JAMA Netw Open 2021;4:e2140364.
DOI: https://doi.org/10.1001/jamanetworkopen.2021.40364
Gambichler T, Scholl L, Dickel H, et al. Prompt onset of Rowell’s syndrome following the first BNT162b2 SARS‐CoV‐2 vaccination. J Eur Acad Dermatol Venereol 2021;35:e415-6.
DOI: https://doi.org/10.1111/jdv.17225
Purushottam M, Rangappa V, Betkerur J, et al. Cutaneous adverse drug reactions (CADRs) to COVID-19 vaccines: a case series. Indian Dermatol Online J 2023;14:383-7.
DOI: https://doi.org/10.4103/idoj.idoj_109_22
World Health Organization. Causality assessment of an adverse event following immunization (AEFI): user manual for the revised WHO classification. 2021. Available from: https://www.who.int/publications/i/item/9789241516990.
Garg RK, Paliwal V, Malhotra HS, et al. Spectrum of serious neurological and psychiatric adverse events in Indian COVID-19 vaccine recipients: a systematic review of case reports and case series. Neurol India 2023;71:209-27.
DOI: https://doi.org/10.4103/0028-3886.375420
How to Cite
Hegde, Megha, Saurav Raj, Dhananjay Tikadar, and Sanatkumar B Nyamagoud. 2023. “Unveiling Vaccine Safety: A Narrative Review of Pharmacovigilance in India’s COVID-19 Vaccination”. Monaldi Archives for Chest Disease, December. https://doi.org/10.4081/monaldi.2023.2793.
Copyright (c) 2023 The Author(s)
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